People want answers and solutions when they have a health problem, especially one like a traumatic brain injury that can alter their whole life and that of their families. Sometimes participating in a clinical trial can give a person the opportunity to play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
That said, it’s important to be informed about a clinical study — its purpose, duration, required procedures, who may or may not be eligible to participate, key contacts, and potential risks and benefits. Agreeing to enter a study and signing the informed consent document is not a contract, and the participant may withdraw from the trial at any time.
To help you better understand clinical trials, here are eight key questions to ask before making any decisions.
1. What exactly is a clinical trial?
Clinical trials are carefully designed research studies in which people help doctors find ways to improve health and care related to specific diseases or medical conditions. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat that condition.
2. Who can participate?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” or "eligibility criteria" and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on factors like age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify, or be eligible to participate in the study.
3. What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. This process is important to ensure that potential participants understand the study’s purpose, potential benefits, and risks in participating as well as their other possible options.
Informed consent is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
4. What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed and reviewed by administrators and other researchers to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
5. What are the benefits of participating in a clinical trial?
Clinical trials that are well-designed and well-executed can help eligible participants to:
- Play an active role in their own healthcare.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading healthcare facilities during the trial.
- Help others by contributing to medical research.
- Some clinical trials offer monetary compensation or reduced treatment costs as an incentive for participation.
6. What are the risks of participating in a clinical trial?
There are definite risks to some clinical trials. For example:
- There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol (medical guidelines for the study) may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
7. Who will be in charge of my care during the clinical trial?
Participants continue to work with their own healthcare doctors, but often the healthcare providers work with the research team to ensure that other medications or treatments will not conflict with the protocol
In fact, participants in clinical trials are often more closely monitored than patients treated outside clinical trials. This is because trial protocol requires detailed collection of health data and frequent patient checkups to assess how patients are doing. In addition, the research doctors typically come from among the clinicians who are most knowledgeable about the disease or condition under study — it’s the focus of their work.
8. Will my safety and privacy be protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names remain secret and are not mentioned in these reports.